CJEU Ruling Clarifies Scope Of Medical Device Definition

The CJEU has delivered a preliminary ruling in Case C-427/24 Diagramm Halbach, which provides guidance on determining whether a product is a medical device within the meaning of Regulation (EU) 2017/745 (“MDR”). The judgment confirms that the manufacturer’s advertising of a product is not necessarily decisive in determining whether it has a “medical purpose” within the definition of “medical device” under the MDR, and that the product must also objectively perform one (or more) of those medical purposes to fall within that definition. The judgment also provides guidance on what constitutes a solely administrative function that does not fall within those medical purposes. The decision has the potential to guide other classification decisions of borderline products used in the healthcare sector.